Clinical Trials Updateshttp://www.bsg.org.uk/research/clinical-trials-updates/index.html
Sat, 10 Dec 2016 03:04:10 +0000Joomla! 1.5 - Open Source Content Managementen-gbNew HRA approval leaflethttp://www.bsg.org.uk/research/clinical-trials-updates/new-hra-approval-leaflet.html
http://www.bsg.org.uk/research/clinical-trials-updates/new-hra-approval-leaflet.htmlThe Health Research Authority (HRA) has published a new brief leaflet setting out high level information about the HRA Approval process. It provides an overview, highlighting their aim to simplify and streamline the approval process. Detailed guidance is also available from the HRA website. For help or to share feedback, contact the HRA directly.]]>j.solomon@bsg.org.uk (Julie Solomon)Clinical Trials UpdatesWed, 30 Nov 2016 13:30:48 +0000I-CARE, a collaborative study of IBD across Europe. http://www.bsg.org.uk/research/clinical-trials-updates/i-care-a-collaborative-study-of-ibd-across-europe.html
http://www.bsg.org.uk/research/clinical-trials-updates/i-care-a-collaborative-study-of-ibd-across-europe.htmlI-CARE, a new collaborative study of IBD across Europe under the auspices of ECCO & GETAID, has been launched in the UK following NIHR portfolio adoption. The flyer gives a summary of the study. It is open for participation by all gastroenterologists in the UK with a suitable cohort of IBD patients.

If you require any further information on the study or are interested in participating, please email the I-CARE national co-ordinators (Shaji Sebastian, Ailsa Hart or Tariq Ahmad).

The UK Clinical Research Collaboration (UKCRC) Registered CTU Network is a network of academic clinical trials units (CTUs) that have been assessed by an international panel of experts in clinical trials research. This site is the authoritative web resource for information about the UKCRC Registered Clinical Trials Units. The information provided on this site is aimed at the following groups, both within and outside the UK:

Clinical researchers and investigators

Clinical research networks

Funders of clinical research (both industry and non-industry)

The site offers a resource for clinical researchers and funders wishing to identify CTUs that have expertise in centrally coordinating multicentre clinical trials, as well as in trial design, data management, and analysis. It provides comprehensive information and direct access to high quality CTUs across the UK which have achieved UKCRC Registration status.

]]>j.solomon@bsg.org.uk (Julie Solomon)Clinical Trials UpdatesFri, 27 Nov 2015 12:02:49 +0000Can aspirin stop cancer?http://www.bsg.org.uk/research/clinical-trials-updates/can-aspirin-stop-cancer.html
http://www.bsg.org.uk/research/clinical-trials-updates/can-aspirin-stop-cancer.htmlThe world’s largest ever clinical trial looking at whether taking aspirin every day stops some of the most common cancers coming back launched on 22 October 2015. The Add-Aspirin phase III trial, the largest of its kind and funded by the NIHR HTA Programme and Cancer Research UK, aims to find out if taking aspirin every day for five years can stop or delay cancers that have been caught and treated at an early stage from returning. It will also study how the drug might do this. The study will recruit 11,000 patients who have recently had, or are having, treatment for bowel, breast, oesophagus (food pipe), prostate or stomach cancer. It will be open at more than 100 centres across the UK and will run for up to 12 years. Details of the trial and the background to it are available on the NIHR website.]]>j.solomon@bsg.org.uk (Julie Solomon)Clinical Trials UpdatesWed, 11 Nov 2015 16:54:43 +0000Join the PANTS Study!http://www.bsg.org.uk/research/clinical-trials-updates/join-the-pants-study.html
http://www.bsg.org.uk/research/clinical-trials-updates/join-the-pants-study.htmlInclusion of patients receiving Biosimilar Infliximab - Remsima™ & Inflectra™

Dr Tariq Ahmad

The latest version of the PANTS protocol allows the inclusion of Crohn's disease patients receiving Biosimilar Infliximab. Specifically this allows

The PANTS study is a prospective uncontrolled cohort study investigating primary non-response, loss of response and adverse drug reactions to Infliximab and Adalimumab in patients with severe active luminal Crohn's disease. The study started in March 2013 and to date 1200 patients aged over 6 years have been recruited from 118 UK hospitals. The collection of clinical data is aligned and shared with the Royal College of Physicians UK IBD Biologics Audit (and in due course with the UK IBD registry), and individual patient laboratory data is released on the web portal.

Biosimilar Infliximab became available in the UK in February 2015 offering significant savings to the National Health Service. Extensive non-clinical and clinical data have shown comparability with the reference product, Remicade™. However the clinical data to date has emerged from the use of Biosimilar Infliximab in studies of patients with Ankylosing Spondylitis and Rheumatoid Arthritis. The PANTS study will report the initial UK experience of Biosimilar Infliximab in Crohn's disease, providing important post-authorisation data on efficacy (at week 14, 30 and 54), safety (to 3 years) and pharmacokinetics. We aim to include 225 patients treated with Biosimilar Infliximab as first-line anti-TNF treatment and 100 PANTS "switchers" over the next 12 months. Please do consider recruiting your patients to the PANTS study.

]]>h.ellison@bsg.org.uk (howard)Clinical Trials UpdatesWed, 01 Jul 2015 14:32:48 +0000Paediatric European Digestive Diseases Clinical Research Network – PEDDCReNhttp://www.bsg.org.uk/research/clinical-trials-updates/paediatric-european-digestive-diseases-clinical-research-network-–-peddcren.html
http://www.bsg.org.uk/research/clinical-trials-updates/paediatric-european-digestive-diseases-clinical-research-network-–-peddcren.htmlPEDDCReN was an exciting new initiative with the key aim of forming a clinical trials network to study (and ultimately provide) effective medicines for paediatric patients in the speciality of Gastroenterology, Hepatology and Nutrition. It was established with the support of LINK funding from the UEG and was led by the BSG in collaboration with various European societies and ENPR-EMA (The European Network of Paediatric Research at the European Medicines Agency). The project supported both industry and non-industry investigators in running high quality multi-centre clinical trials. The final report has now been published.

]]>h.ellison@bsg.org.uk (howard)Clinical Trials UpdatesTue, 31 Mar 2015 10:48:08 +0000HCV clinical trial and tissue biobankhttp://www.bsg.org.uk/research/clinical-trials-updates/hcv-clinical-trial-and-tissue-biobank.html
http://www.bsg.org.uk/research/clinical-trials-updates/hcv-clinical-trial-and-tissue-biobank.htmlHCV Research UK is a national cohort of over 11,000 patients enrolled between 2012 and 2014 from 60 centres within the UK with evidence of hepatitis C virus infection. All patients have enrolled with written informed consent, which allows storage of routinely collected clinical data in a linked-anonymised database, and have donated biological samples to a biorepository (held in Glasgow).

The purpose of HCV Research UK is to act as a resource to support research into a range of aspects of HCV infection.

Applications for access to data and/or samples may be made through the HCV Research UK Tissue and Data Access Committee through completion of an on-line application form.